Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients

NCT ID: NCT02629965

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-12
• Study Completion Date: 2017-04-17

Brief Summary

This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tiotropium + olodaterol

inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning

Group Type: EXPERIMENTAL

tiotropium

Intervention Type: DRUG

fixed dose combination

olodaterol

Intervention Type: DRUG

fixed dose combination

tiotropium

inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning

Group Type: ACTIVE_COMPARATOR

tiotropium

Intervention Type: DRUG

Interventions

tiotropium

fixed dose combination

Intervention Type: DRUG

olodaterol

fixed dose combination

Intervention Type: DRUG

tiotropium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
• All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following spirometric criteria:

Patients must have relatively stable airway obstruction with a post-bronchodilator Forced expiratory volume in one second (FEV1) < 80% of predicted normal and post-bronchodilator FEV1/forced vital capacity (FVC) < 70% at Visit 1.

• Male or female patients, aged >= 40 years.
• Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
• Patients with score on the modified Medical Research Council (mMRC) >= 1.
• Patients who walk < 400 meters of 6MWT and have a score on the modified Borg >= 4 at the end of 6 minute walk test (6MWT) at Visit 2.
• Patients must be able to perform technically acceptable pulmonary function tests (spirometry), to use the physical activity monitor and must be able to complete 6MWT during the study period as required in the protocol.
• Patients must be able to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler.

Exclusion Criteria

• Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may put the patient at risk because of participation in the study, influence the results of the study and cause concern regarding the patient's ability to participate in the study.
• Patients with clinically relevant abnormal baseline haematology, blood chemistry,urinalysis or creatinine > x2 upper limit of normal (ULN) will be excluded regardless of clinical condition (a repeat laboratory evaluation can be conducted if deemed necessary by the investigator).
• Patients with a current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Hiramatsu Internal and Respiratory Medicine Clinic

Aichi, Komaki, , Japan

National Hospital for Geriatric Medicine

Aichi, Obu, , Japan

Tosei General Hospital

Aichi, Seto, , Japan

Nishi Fukuoka Hospital

Fukuoka, Fukuoka, , Japan

Kirigaoka Tsuda Hospital

Fukuoka, Kitakyushu, , Japan

Osaki Internal and Respiratory Clinic

Fukuoka, Kitakyushu, , Japan

Kurume University Hospital

Fukuoka, Kurume, , Japan

Tohno Chuo Clinic

Gifu, Mizunami, , Japan

Mazda Hospital

Hiroshima, Aki-gun, , Japan

Teine Keijinkai Clinic

Hokkaido, Sapporo, , Japan

Hokkaido University Hospital

Hokkaido, Sapporo, , Japan

KKR Sapporo Medical Center

Hokkaido, Sapporo, , Japan

Japan Community Health Care Organization Hokkaido Hospital

Hokkaido, Sapporo, , Japan

Kobe City Medical Center General Hospital

Hyogo, Kobe, , Japan

Kobe City Hospital Organization Kobe City Medical Center West Hospital

Hyogo, Kobe, , Japan

Ibarakihigashi National Hospial

Ibaraki, Naka-gun, , Japan

Iwate Medical University Hospital

Iwate, Morioka, , Japan

Sakaide City Hospital

Kagawa, Sakaide, , Japan

Kagoshima University Medical And Dental Hospital

Kagoshima, Kagoshima, , Japan

Kokan Clinic

Kanagawa, Kawasaki, , Japan

Shin-yurigaoka General Hospital

Kanagawa, Kawasaki, , Japan

Showa University Fujigaoka Hospital

Kanagawa, Yokohama, , Japan

Kyoto University Hospital

Kyoto, Kyoto, , Japan

Rakuwakai Otowa Hospital

Kyoto, Kyoto, , Japan

Uji-Tokushukai Medical Center

Kyoto, Uji, , Japan

Matsusaka City Hospital

Mie, Matsusaka, , Japan

Tohoku University Hospital

Miyagi, Sendai, , Japan

Tohoku Rosai Hospital

Miyagi, Sendai, , Japan

Kishiwada City Hospital

Osaka, Kishiwada, , Japan

Kindai University Hospital

Osaka, Osakasayama, , Japan

Osaka City University Hospital

Osaka, Osaka, , Japan

National Hospital Organization Toneyama National Hospital

Osaka, Toyonaka, , Japan

Yao Tokushukai General Hospital

Osaka, Yao, , Japan

Shimane University Hospital

Shimane, Izumo, , Japan

Tenryu Hospital

Shizuoka, Hamamatsu, , Japan

Juntendo University Hospital

Tokyo, Bunkyo-ku, , Japan

The Respiratory Care Clinic, Nippon Medical School

Tokyo, Chiyoda-ku, , Japan

Nihonbashi Sakura Clinic

Tokyo, Chuo-ku, , Japan

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, , Japan

Nihon University Itabashi Hospital

Tokyo, Itabashi-ku, , Japan

Showa University Hospital

Tokyo, Shinagawa-ku, , Japan

Shinjuku Research Park Clinic

Tokyo, Shinjuku-ku, , Japan

Wakayama National Hospital

Wakayama, Hidaka-gun, , Japan

Countries

Japan

References

Minakata Y, Motegi T, Ueki J, Gon Y, Nakamura S, Anzai T, Hirata K, Ichinose M. Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO(R) study. Int J Chron Obstruct Pulmon Dis. 2019 Aug 7;14:1789-1801. doi: 10.2147/COPD.S208081. eCollection 2019.

Reference Type: DERIVED

PMID: 31496678 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

1237.33

Identifier Type: -

Identifier Source: org_study_id